Course Summary

A clinical investigator is responsible for conducting the clinical trial in compliance with the study protocol, GCP, medical ethics, and applicable legal requirements. The clinical research community expects that investigators and clinical staff are fully trained in GCP. Duties and functions discussed in this short course include: provision of adequate resources; liaison with IRB/IEC; compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.

Who will benefit from this module?

This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.

Learning Objectives

• Identify qualifications and resources that an investigator should be able to demonstrate
• Describe the extent to which deviation from the protocol is acceptable
• Discuss the management of investigational products
• Describe how data should be recorded and corrected and how records should be maintained
• Classify adverse events and specify criteria for reporting them

Module Outline

Key topics covered in this module include:

• Qualifications and resources
• Liaison with IRB/IEC
• Compliance with protocol
• Management of investigational product(s)
• Informed consent
• Data records
• Safety reporting

Assessment - Multiple-choice assessment.